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Blood. 2018 Jul 12;132(2):223-231. doi: 10.1182/blood-2018-02-831289. Epub 2018 May 17.

Hemostatic efficacy of pathogen-inactivated vs untreated platelets: a randomized controlled trial.

Author information

1
Center for Clinical Transfusion Research-Sanquin, Leiden, The Netherlands.
2
Department of Hematology, HagaZiekenhuis, Den Haag, The Netherlands.
3
Department of Medical Statistics and Bioinformatics and.
4
Department of Immunohematology and Blood Bank, Leiden University Medical Center, Leiden, The Netherlands.
5
Juravinsky Hospital, Hamilton, ON, Canada.
6
Maastricht University Medical Center, Maastricht, The Netherlands.
7
Erasmus Medical Center, Rotterdam, The Netherlands.
8
Ottawa Hospital, Ottawa, ON, Canada.
9
Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
10
London Health Sciences Center, London, ON, Canada.
11
Kingston General Hospital, Kingston, ON, Canada.
12
Blood Systems Research Institute, San Francisco, CA.
13
Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO.
14
Haukeland University Hospital, Bergen, Norway.
15
Department of Medicine, McMaster University, Hamilton, ON, Canada; and.
16
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Abstract

Pathogen inactivation of platelet concentrates reduces the risk for blood-borne infections. However, its effect on platelet function and hemostatic efficacy of transfusion is unclear. We conducted a randomized noninferiority trial comparing the efficacy of pathogen-inactivated platelets using riboflavin and UV B illumination technology (intervention) compared with standard plasma-stored platelets (control) for the prevention of bleeding in patients with hematologic malignancies and thrombocytopenia. The primary outcome parameter was the proportion of transfusion-treatment periods in which the patient had grade 2 or higher bleeding, as defined by World Health Organization criteria. Between November 2010 and April 2016, 469 unique patients were randomized to 567 transfusion-treatment periods (283 in the control arm, 284 in the intervention arm). There was a 3% absolute difference in grade 2 or higher bleeding in the intention-to-treat analysis: 51% of the transfusion-treatment periods in the control arm and 54% in the intervention arm (95% confidence interval [CI], -6 to 11; P = .012 for noninferiority). However, in the per-protocol analysis, the difference in grade 2 or higher bleeding was 8%: 44% in the control arm and 52% in the intervention arm (95% CI -2 to 18; P = .19 for noninferiority). Transfusion increment parameters were ∼50% lower in the intervention arm. There was no difference in the proportion of patients developing HLA class I alloantibodies. In conclusion, the noninferiority criterion for pathogen-inactivated platelets was met in the intention-to-treat analysis. This finding was not demonstrated in the per-protocol analysis. This trial was registered at The Netherlands National Trial Registry as #NTR2106 and at www.clinicaltrials.gov as #NCT02783313.

PMID:
29773572
DOI:
10.1182/blood-2018-02-831289
[Indexed for MEDLINE]

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